Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00783848
First received: October 30, 2008
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.

The purpose of this research study is to learn about the experience and impact of having congestive heart failure (CHF). In particular, we hope to develop better questionnaires that can measure heart failure patients' quality-of-life.


Condition
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Evaluate the validity (including responsiveness) of selected PROMIS domains for patients with severe heart failure who receive a heart transplant. [ Time Frame: baseline and 8-12 weeks post-transplant ] [ Designated as safety issue: No ]
    Clinical and patient-reported assessments will be performed at baseline and 8-12 weeks 86 (end of study). Clinical indicators of functioning will include the New York Heart 87 Association (NYHA) classification and the six-minute walk test. We will include the 88 Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific measure of health-89 related quality of life (HRQOL), as a point of reference for understanding the relative 90 validity (including responsiveness) of the PRPROMIS item banks. Instruments will include 91 PROMIS computerized adaptive tests (CATS).


Enrollment: 58
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This project will assess the validity (including responsiveness) of selected Patient Reported Outcome Measurement Information System (PROMIS) instruments in patients with severe CHF who receive heart transplants. The following is a list of goals for this project:

  • To estimate the responsiveness of PROMIS domain scores by comparing scores in patients with severe heart failure before and after a clinically significant event (heart transplant). The specific PROMIS domains assessed are physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
  • To estimate the responsiveness of a disease-specific patient-reported outcome (PRO) measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-36 Vitality subscale (SF-36v2), and the Patient Health Questionnaire (PHQ-2).
  • To collect cross-sectional and longitudinal data on traditional clinical measures of heart failure outcome (6-minute walk test and New York Heart Association [NYHA] class) that can inform the definition of a minimally important difference (MID) for the PROMIS domains of physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited through heart transplant program registries and in consultation with practicing cardiologists at Duke University, Stanford University, and the University of Pittsburgh.

Criteria

Inclusion Criteria:

  • Heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist
  • Ability to read, write, and speak in English
  • Ability to understand and provide informed consent
  • Placement on heart transplant registry (awaiting heart transplant surgery)

Exclusion Criteria:

  • Current diagnosis of psychosis or dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783848

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Duke University
University of Pittsburgh
Investigators
Principal Investigator: Kevin Weinfurt, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00783848     History of Changes
Other Study ID Numbers: Pro00009919, 5U01AR052186-02
Study First Received: October 30, 2008
Last Updated: April 26, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014